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M. Satouchi
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New approaches in rare thoracic tumors (ID 60)
- Event: ELCC 2018
- Type: Proffered Paper session
- Track:
- Presentations: 1
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112O - Primary result of an investigator-initiated phase II trial of nivolumab for unresectable or recurrent thymic carcinoma: PRIMER study (NCCH1505) (ID 349)
11:00 - 12:30 | Author(s): M. Satouchi
- Abstract
- Presentation
Background:
Thymic carcinoma (TC) is a rare cancer with a poor prognosis. Treatment options are limited, especially after relapse. We previously reported that PD-L1 positivity was observed in 70% of TCs by immunohistochemistry suggesting anti PD-1/PD-L1 agents could be a promising treatment.
Methods:
In this open-label, two-stage, multi-center, single-arm, phase II trial, the main eligibility criteria were: unresectable or recurrent TC, an ECOG-PS of 0 or 1, the presence of measurable disease, progression after at least one previous platinum-based chemo(radio)therapy treatment, and no history of autoimmune disease. Nivolumab was administered at a dose of 3 mg/kg every 2 weeks. The primary endpoint was the response rate (RR) as evaluated by central review using the RECIST v1.1; secondary endpoints include progression-free survival (PFS), overall survival, disease control rate, and safety. The planned sample size was 15 for the first stage and 15 for the second stage, with a threshold RR of 5%, an expected RR of 20%, one-sided alpha of 5% and power of 80%. This trial was registered with UMIN000022007.
Results:
Between July 1 and August 16, 2016, 15 patients were accrued in the first stage; at the data cutoff (August 31, 2017), all were assessable for a response. Median follow-up time was 3.8 months (range 1.4–12.0). All were Japanese, 12 were male, median age was 55 (range 34–70), 13 had squamous histology. The median number of nivolumab cycles received was 8 (range 3–29). RR by central review was 0% (no patient with complete or partial response; 95% confidence interval [CI]: 0–21.8). Eleven patients had stable disease and four had progressive disease. Median PFS was 3.8 months (95% CI: 1.9–5.6), and 12-month PFS rate was 13.3% (95% CI: 2.2–34.6). Two patients experienced a treatment-related serious adverse events (grade 3 AST increase and grade 2 adrenal insufficiency). Because the early termination criteria at the first stage (less than one responder) was fulfilled, the patient accrual was terminated.
Conclusions:
Despite of the small number of patients, our results suggested further development of nivolumab is not recommended in previously treated unresectable or recurrent TC.
Clinical trial identification:
Legal entity responsible for the study:
None
Funding:
Japan Agency for Medical Research and Development
Disclosure:
T. Seto: Consulting and advisory services, speaking or writing engagements, public presentations; AstraZeneca, Bristol-Myers Squibb, Chugai, Eli Lilly, MSD, Nippon Boehringer Ingelheim, Ono, Pfizer, Taiho, Takeda. Direct research support to the responsible project lead (e.g., Principal Investigator); Eisai, MSD, Nippon Boehringer Ingelheim, AstraZeneca, Astellas, Chugai, Daiichi Sankyo, Eli Lilly, Merck Serono, Novartis, Pfizer. H. Horinouchi: Research Grant; Ono pharmaceutical, BMS, MSD, Taiho, Chugai, Novartis, Astellas, Merck Serono. Honoraria; Ono pharmaceutical, BMS, Taiho, Chugai, Novartis, Lilly, AstraZeneca. S. Umemura: Corporate-sponsored research; MSD, AstraZeneca. Honoraria; AstraZeneca, Chugai pharmaceutical, Ono, Boehringer ingelheim. Y. Hosomi: Honoraria; Lilly, Ono pharmaceutical, BMS, Chugai, AstraZeneca. Corporate-sponsored research; Lilly, Ono pharmaceutical, Chugai, AstraZeneca, Taiho, MSD. M. Satouchi: Corporate-sponsored research; Astellas Pharma, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai Pharmaceutical, Eli Lilly Japan, Novartis, Ono Pharmaceutical, Pfizer Japan. Lecture fees and/or honoraria; AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai Pharmaceutical, Eli Lilly Japan, Merck, Novartis, Ono Pharmaceutical, Pfizer Japan, Taiho Pharmaceutical. Y. Ohe: Corporate-sponsored research; Taiho, AstraZeneca, Chugai, Lilly, Pfizer, MSD, Novartis, Kyorin, Dainippon-Sumitomo, Ignyta. Membership on an advisory board or board of directors or other substantive relationships; Taiho, AstraZeneca, Chugai, Lilly, Pfizer, MSD, Novartis, Daiichi-Sankyo, Nipponkayaku, Boehringer Ingelheim, Bayer. All other authors have declared no conflicts of interest.
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Poster Display session (Friday) (ID 65)
- Event: ELCC 2018
- Type: Poster Display session
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 4/13/2018, 12:30 - 13:00, Hall 1
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171P - A phase I/II study of weekly nab-paclitaxel plus cisplatin in chemotherapy-naïve patients with advanced non-small cell lung cancer (ID 300)
12:30 - 13:00 | Author(s): M. Satouchi
- Abstract
Background:
In the treatment of non-small-cell lung cancer (NSCLC), solvent-based paclitaxel (sb-paclitaxel) plus cisplatin can be expected to have high response rate, but strong neurotoxicity is observed. Currently, nanoparticle albumin-bound paclitaxel (nab-paclitaxel) plus carboplatin is considered as one of the standard regimen, and a higher response rate and lower neurotoxicity are expected as compared with sb-paclitaxel plus carboplatin. Therefore, we planned this study to evaluate the efficacy and safety of nab-paclitaxel plus cisplatin in chemotherapy-naïve patients with advanced NSCLC.
Methods:
Chemotherapy-naïve patients with advanced NSCLC were eligible. In phase 1 dose escalation cohort (3 + 3 design), patients received nab-paclitaxel (80 or 100 mg/m[2] iv on days 1, 8 and 15) plus cisplatin (60 or 75 mg/m[2] iv on day 1) every 4 weeks. The maximum tolerated dose was not reached. Nab-paclitaxel (100 mg/m[2] iv on days 1, 8 and 15) plus cisplatin (75 mg/m[2] iv on day1) every 4 weeks was selected for phase 2 cohort. The primary endpoint was objective response rate (ORR).
Results:
23 patients (phase 1, n = 6; phase 2, n = 17) were enrolled from October 2013 to September 2017, and 22 patients were eligible. The median age was 67.5 years (range 37–75 years), 90.9% were males, 100% had smoked, 45.5% had adenocarcinoma and 81.8% had Stage IV. The ORR was 59.1% (95% confidence interval (CI); 38.7–76.7%) and the disease control rate was 86.4% (95% CI; 66.7–95.3%). The median progression free survival was 5.1 months (95% CI; 4.0–6.7 months) and the median overall survival was 24.2 months (95% CI; 8.4- not estimable (NE) months). The common grade ≥ 3 adverse events was neutropenia (31.8%), leukopenia (27.3%), lung infection (18.2%) and hyponatremia (18.2%). There was one grade 2 interstitial pneumonia and no treatment related death.
Conclusions:
Nab-paclitaxel plus cisplatin was well tolerated and associate with encouraging response outcomes in chemotherapy-naïve patients with advanced NSCLC. Further investigation is warranted.
Clinical trial identification:
UMIN000011776 (17 Sep 2013)
Legal entity responsible for the study:
N/A
Funding:
Taiho Pharmaceutical
Disclosure:
Y. Hattori: Honoraria: Astra Zeneca, Boehringer Ingelheim, Chugai Pharmaceutical, Eli Lilly, MSD, Novartis, Ono Pharmaceutical, Taiho Pharmaceutical Research funding: Bristol-Myers Squibb, MSD. S. Morita: Honoraria: Taiho Pharmaceutical. F. Imamura: Honoraria: Taiho Pharmaceutical Research funding: Taiho Pharmaceutical. M. Satouchi: Honoraria: Astra Zeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai Pharmaceutical, Eli Lilly, MSD, Novartis, Ono Pharmaceutical, Pfizer, Taiho Pharmaceutical Research funding: Astellas, Astra Zeneca, Bristol-Myers Squibb, Chugai Pharmaceutical, Eli Lilly, MSD, Ono Pharmaceutical, Novartis, Pfizer. All other authors have declared no conflicts of interest.
